HIVEC in Patients With Non-Muscle-Invasive Bladder Cancer

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAffiliated Cancer Hospital & Institute of Guangzhou Medical University

About this trial

The purpose of this study is to determine the efficacy and safety of Hyperthermic Intravesical Chemotherapy (HIVEC) with Gemcitabine (GEM) after Transurethral Resection of Bladder Tumors (TURBT) in the treatment of medium or high-risk group Non-Muscle-Invasive Bladder Cancer (NMIBC).

Eligibility criteria

Qualifiers

Patients who did not receive induction perfusion within 4 weeks after complete resection of bladder tumor with TURBT (Patients who were judged by the investigator to be in need of secondary electrotomy, for the last time).

Recurrence risk and prognosis of Non-Muscle-Invasive Bladder Cancer were divided into medium-risk group or high-risk group (patients who underwent multiple electrosurgical biopsies, and the pathological results were based on higher grade tumors).

KPS score ≥80, expected survival > 30 months.

Pathological suggested non-myoinvasive urothelial carcinoma of the bladder.

Disqualifiers

Patients with bladder cancer in situ.

Combined with proven upper urinary tract or urethral tumors.

The patients were complicated with bladder perforation, gross hematuria or urinary tract infection of grade 3-4.

Patients with urethral discontinuity, urethral stricture, or inability to use a three lumen catheter normally affect perfusion therapy.

Trial design

Treatments tested in this trial

  • TURBT
  • HIVEC
  • Intravesical Chemotherapy
  • Gemcitabine

Treatment groups

320 Participants
are divided into 2 treatment groups

Locations

This trial has no locations